DSM265-HNMR-28524-MedChemExpress
HMN-214_SDS_MedChemExpress
Inhibitors, Agonists, Screening LibrariesSafety Data Sheet Revision Date:May-24-2017Print Date:May-24-20171. PRODUCT AND COMPANY IDENTIFICATION1.1 Product identifierProduct name :HMN-214Catalog No. :HY-12045CAS No. :173529-46-91.2 Relevant identified uses of the substance or mixture and uses advised againstIdentified uses :Laboratory chemicals, manufacture of substances.1.3 Details of the supplier of the safety data sheetCompany:MedChemExpress USATel:609-228-6898Fax:609-228-5909E-mail:sales@1.4 Emergency telephone numberEmergency Phone #:609-228-68982. HAZARDS IDENTIFICATION2.1 Classification of the substance or mixtureGHS Classification in accordance with 29 CFR 1910 (OSHA HCS)Acute toxicity, Oral (Category 4), H302Acute aquatic toxicity (Category 1), H400Chronic aquatic toxicity (Category 1), H4102.2 GHS Label elements, including precautionary statementsPictogramSignal word WarningHazard statement(s)H302 Harmful if swallowed.H410 Very toxic to aquatic life with long lasting effects.Precautionary statement(s)P264 Wash skin thoroughly after handling.P270 Do not eat, drink or smoke when using this product.P273 Avoid release to the environment.P301 + P312 IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell.P330 Rinse mouth.P391 Collect spillage.P501 Dispose of contents/ container to an approved waste disposal plant.2.3 Other hazardsNone.3. COMPOSITION/INFORMATION ON INGREDIENTS3.1 SubstancesSynonyms:IVX⁻214; HMN214; HMN 214; IVX 214; IVX⁻214; IVX214Formula:C22H20N2O5SMolecular Weight:424.47CAS No. :173529-46-94. FIRST AID MEASURES4.1 Description of first aid measuresEye contactRemove any contact lenses, locate eye-wash station, and flush eyes immediately with large amounts of water. Separate eyelids with fingers to ensure adequate flushing. Promptly call a physician.Skin contactRinse skin thoroughly with large amounts of water. Remove contaminated clothing and shoes and call a physician.InhalationImmediately relocate self or casualty to fresh air. If breathing is difficult, give cardiopulmonary resuscitation (CPR). Avoid mouth-to-mouth resuscitation.IngestionWash out mouth with water; Do NOT induce vomiting; call a physician.4.2 Most important symptoms and effects, both acute and delayedThe most important known symptoms and effects are described in the labelling (see section 2.2).4.3 Indication of any immediate medical attention and special treatment neededTreat symptomatically.5. FIRE FIGHTING MEASURES5.1 Extinguishing mediaSuitable extinguishing mediaUse water spray, dry chemical, foam, and carbon dioxide fire extinguisher.5.2 Special hazards arising from the substance or mixtureDuring combustion, may emit irritant fumes.5.3 Advice for firefightersWear self-contained breathing apparatus and protective clothing.6. ACCIDENTAL RELEASE MEASURES6.1 Personal precautions, protective equipment and emergency proceduresUse full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas.Refer to protective measures listed in sections 8.6.2 Environmental precautionsTry to prevent further leakage or spillage. Keep the product away from drains or water courses.6.3 Methods and materials for containment and cleaning upAbsorb solutions with finely-powdered liquid-binding material (diatomite, universal binders); Decontaminate surfaces and equipment by scrubbing with alcohol; Dispose of contaminated material according to Section 13.7. HANDLING AND STORAGE7.1 Precautions for safe handlingAvoid inhalation, contact with eyes and skin. Avoid dust and aerosol formation. Use only in areas with appropriate exhaust ventilation.7.2 Conditions for safe storage, including any incompatibilitiesKeep container tightly sealed in cool, well-ventilated area. Keep away from direct sunlight and sources of ignition.Recommended storage temperature:Powder-20°C 3 years4°C 2 yearsIn solvent-80°C 6 months-20°C 1 monthShipping at room temperature if less than 2 weeks.7.3 Specific end use(s)No data available.8. EXPOSURE CONTROLS/PERSONAL PROTECTION8.1 Control parametersComponents with workplace control parametersThis product contains no substances with occupational exposure limit values.8.2 Exposure controlsEngineering controlsEnsure adequate ventilation. Provide accessible safety shower and eye wash station.Personal protective equipmentEye protection Safety goggles with side-shields.Hand protection Protective gloves.Skin and body protection Impervious clothing.Respiratory protection Suitable respirator.Environmental exposure controls Keep the product away from drains, water courses or the soil. Cleanspillages in a safe way as soon as possible.9. PHYSICAL AND CHEMICAL PROPERTIES9.1 Information on basic physical and chemical propertiesAppearance White to off-white (Solid)Odor No data availableOdor threshold No data availablepH No data availableMelting/freezing point No data availableBoiling point/range No data availableFlash point No data availableEvaporation rate No data availableFlammability (solid, gas)No data availableUpper/lower flammability or explosive limits No data availableVapor pressure No data availableVapor density No data availableRelative density No data availableWater Solubility No data availablePartition coefficient No data availableAuto-ignition temperature No data availableDecomposition temperature No data availableViscosity No data availableExplosive properties No data availableOxidizing properties No data available9.2 Other safety informationNo data available.10. STABILITY AND REACTIVITY10.1 ReactivityNo data available.10.2 Chemical stabilityStable under recommended storage conditions.10.3 Possibility of hazardous reactionsNo data available.10.4 Conditions to avoidNo data available.10.5 Incompatible materialsStrong acids/alkalis, strong oxidising/reducing agents.10.6 Hazardous decomposition productsUnder fire conditions, may decompose and emit toxic fumes.Other decomposition products - no data available.11.TOXICOLOGICAL INFORMATION11.1 Information on toxicological effectsAcute toxicityClassified based on available data. For more details, see section 2Skin corrosion/irritationClassified based on available data. For more details, see section 2Serious eye damage/irritationClassified based on available data. For more details, see section 2Respiratory or skin sensitizationClassified based on available data. For more details, see section 2Germ cell mutagenicityClassified based on available data. For more details, see section 2CarcinogenicityIARC: No component of this product present at a level equal to or greater than 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.ACGIH: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by ACGIH.NTP: No component of this product present at a level equal to or greater than 0.1% is identified as a anticipated or confirmed carcinogen by NTP.OSHA: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by OSHA.Reproductive toxicityClassified based on available data. For more details, see section 2Specific target organ toxicity - single exposureClassified based on available data. For more details, see section 2Specific target organ toxicity - repeated exposureClassified based on available data. For more details, see section 2Aspiration hazardClassified based on available data. For more details, see section 212. ECOLOGICAL INFORMATION12.1 ToxicityNo data available.12.2 Persistence and degradabilityNo data available.12.3 Bioaccumlative potentialNo data available.12.4 Mobility in soilNo data available.12.5 Results of PBT and vPvB assessmentPBT/vPvB assessment unavailable as chemical safety assessment not required or not conducted.12.6 Other adverse effectsNo data available.13. DISPOSAL CONSIDERATIONS13.1 Waste treatment methodsProductDispose substance in accordance with prevailing country, federal, state and local regulations.Contaminated packagingConduct recycling or disposal in accordance with prevailing country, federal, state and local regulations.14. TRANSPORT INFORMATIONDOT (US)This substance is considered to be non-hazardous for transport.IMDGUN number: 3077Class: 9Packing group: IIIEMS-No: F-A, S-FProper shipping name: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.Marine pollutant: Marine pollutantIATAUN number: 3077Class: 9Packing group: IIIProper shipping name: Environmentally hazardous substance, solid, n.o.s.15. REGULATORY INFORMATIONSARA 302 Components:No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.SARA 313 Components:This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.SARA 311/312 Hazards:No SARA Hazards.Massachusetts Right To Know Components:No components are subject to the Massachusetts Right to Know Act.Pennsylvania Right To Know Components:No components are subject to the Pennsylvania Right to Know Act.New Jersey Right To Know Components:No components are subject to the New Jersey Right to Know Act.California Prop. 65 Components:This product does not contain any chemicals known to State of California to cause cancer, birth defects, or anyother reproductive harm.16. OTHER INFORMATIONCopyright 2017 MedChemExpress. The above information is correct to the best of our present knowledge but does not purport to be all inclusive and should be used only as a guide. The product is for research use only and for experienced personnel. It must only be handled by suitably qualified experienced scientists in appropriately equipped and authorized facilities. The burden of safe use of this material rests entirely with the user. MedChemExpress disclaims all liability for any damage resulting from handling or from contact with this product.Caution: Product has not been fully validated for medical applications. For research use only.Tel: 609-228-6898 Fax: 609-228-5909 E-mail: tech@Address: 1 Deer Park Dr, Suite Q, Monmouth Junction, NJ 08852, USA。
脑海绵状血管瘤的诊断及手术治疗的临床分析
临床研究脑海绵状血管瘤的诊断及手术治疗的临床分析牧仁内蒙古赤峰学院附属医院，内蒙古 赤峰 024000【摘要】目的：研究脑海绵状血管瘤的诊断方法，采用手术治疗的临床效果。
方法：选取2018年11月至2020年11月本院收治的脑海绵状血管瘤患者60例，对患者进行CT和MRI进行临床诊断，所有患者均接受了手术治疗，总结分析手术治疗后的临床效果，采用卡氏评分指标对患者手术前后的功能状况进行评分比较。
结果：通过CT和MRI进行临床诊断，脑海绵状血管瘤可发生在脑内任何部位，其中额叶11例、颞叶12例、延髓15例、小脑半球10例、右基底节区12例，CT平扫为稍高密度影，部分病例可见钙化灶，注药后大都无强化，急性出血患者34例，非急性出血患者26例；通过手术治疗，患者的临床症状得到明显缓解，卡氏评分与手术前相比较得到明显的改善。
结论：临床对于脑海绵状血管瘤的诊断采用CT联合MRI进行具有明显的临床价值，对于患者后续的治疗方案具有重要的指导意义，临床采用手术治疗方法效果较好。
【关键词】脑海绵状血管瘤；诊断；手术治疗；临床分析【中图分类号】R781.4 【文献标识码】A 【文章编号】2096-5249(2022)27-0081-03脑海绵状血管瘤（Cavernous Hemangioma, CH）是脑血管畸形的类型，一般的剪影血管造影技术难以发现，故又称为隐匿性血管畸形。
它并非真正的肿瘤，而是一种缺乏动脉成分的血管畸形。
它被认为是一种少见的血管畸形，可发生于脑的任何部位。
此血管瘤是由大小不等的血管窦所组成，管壁与毛细血管壁相似，多发生在大脑各叶、脑室壁、鞍区、桥小脑脚、小脑及硬脑膜上。
血管瘤大小不等，小为数毫米，大者直径可达3~4 cm，呈鲜红色或草莓状，易自发出血或血栓形成。
临床表现一般不引起症状，但位于鞍区者可出现视力与视野的改变；位于桥小脑角者与听神经瘤症状相似；有血肿形成则有各种局灶压迫症状。
但是近年来脑海绵状血管瘤的发病率呈现递增的趋势，由于脑海中的神经系统比较发达，该种疾病的病灶较多多位于脑中功能区，情况严重的会导致神经功能障碍，甚至造成患者的残疾，给患者的日常生活造成严重的影响，因此需要根据患者的临床诊断病症情况不同选择合适的手术治疗方案进行干预，提升患者的治愈率和生活质量[1]。
Sigma-Aldrich是全世界领先的生命科学与高科技集团公司。
Sigma-Aldrich 是全世界领先的生命科学与高科技集团公司。
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SIGMA 原装促销欢迎垂询！sigma 51370 Harmane 1G 现货sigma 222984 dl-Propranolol HCl 5G 现货sigma 284785 S-6-Methoxy-a-Methyl-2-Naphthaleneacetic acid 25G 现货sigma 857416 3-(3,4-Dihydroxyphenyl)-2-methyl-L-Alanine 5g 现货sigma 857440 Chloramphenicol 25G 现货sigma A4669 Acycloguanosine 500mg 现货sigma A5882 Antipyrine 500G 现货sigma A7655 Atenolol 25G 现货sigma A8523 Amoxicillin 25g 现货sigma B7283 Benserazide HCl 5G 现货sigma C2505 Corticosterone 500MG 现货sigma C4024 Carbamazepine 25G 现货sigma C4216 Coumarin 500G 现货sigma C4255 Creatinine 1KG 现货sigma C4522 Cimetidine 25G 现货sigma C5793 Ceftriaxone Na 1G 现货sigma C6022 Cyproheptadin HCl 1G 现货sigma D1756 Dexamethasone 500MG 现货sigma D2521 Diltiazem 10G 现货sigma D4007 Phenytoin 500G 现货sigma D6270 1-(2,6-dichlorobenzyl-ideneamino)guanidine 100MG 现货sigma D9628 l-3,4-Dihydroxyphenyl-alanine 100G 现货sigma E6888 Enalapril Maleat 5G 现货sigma F4381 Furosemide 25G 现货sigma F8514 Flurbiprofen 25G 现货sigma F9677 Felodipine 25MG 现货sigma H0888 Hydrocortisone 10G 现货sigma H4759 Hydrochlorothiazide 100G 现货sigma I0899 Imipramine HCl 25G 现货sigma K1751 Ketoprofen 100G 现货sigma M5391 Metoprolol x 1/2 Tartrate 10G 现货sigma N144 Nitrendipine 500MG 现货sigma N7758 Naloxone 1G 现货sigma N8280 Naproxen 5G 现货sigma N9890 Norfloxacin 25G 现货sigma P0847 Piroxicam 10G 现货sigma P7412 Pirenzepine 1G 现货sigma Q3625 Quinidine 25G 现货sigma R101 Ranitidine 5G 现货sigma S0883 Sulfasalazine 100G 现货sigma S8010 Sulpiride 100G 现货sigma T1500 Testosterone 25G 现货sigma T2528 Terbutaline x 1/2 Tartrate 5G 现货sigma T69809 Trimethoxybenzamide HCl 100G 现货sigma V4629 Verapamil 10G 现货sigma E3763 Ethoxyresorufin 5MG 现货sigma A2500 Phenacetin 100G 现货sigma UC175 S-(+)Mephenytoin 5MG 现货sigma T1912 Paclitaxel 25MG 现货sigma UC214 S-Warfarin 10MG 现货sigma D6899 Diclofenac sodium salt 10G 现货sigma O104 Omeprazole 500MG 现货sigma D9684 Dextromethorphan hydrobromide 5G 现货sigma UC168 (±)-Bufuralol hydrochloride 10MG 现货sigma C4397 Chlorzoxazone 25G 现货sigma H24003 Umbelliferone 10G 现货sigma A7085 Acetaminophen 100G 现货sigma UC126 4-hydroxymephenytoin 5MG 现货sigma T2573 Troglitazone 5MG 现货sigma UC211 7-hydroxywarfarin 5MG 现货sigma H3661 4'-hydroxydiclofenac 1VL 现货sigma UC179 (R)-(?)-Nirvanol 5MG 现货sigma H147 Hydroxybufuralol maleate 2MG 现货sigma C188 6-Hydroxychlorzoxazone 5MG 现货sigma H2898 6β-Hydroxytestosterone 5MG 现货sigma M3501 8-Methoxypsoralen 1G 现货sigma S0758 Sulfaphenazole 1G 现货sigma C1240 Clomethiazole 10MG 现货sigma K1003 Ketoconazole 100MG 现货sigma T6514 Oleandomycin triacetate 1G 现货sigma D127 Dextrorphan tartrate 500MG 现货sigma Merck 580559 6alpha-OH-paclitaxel 5 mg 现货sigma N6505 NADPH (reduced form) 100 mg 现货sigma o3639 Ondansetron (7, 8) 50 mg 现货sigma UC448 Paracetamol 5 mg 现货sigma T5648 Tamoxifen (N-demethylation) 1g 现货sigma M4267 Mefenamic acid (3-methyl) 50g 现货sigma R2625 Retinoic acid (Tretinoin) 1g 现货sigma T0909 Tenoxicam (5') 1g 现货sigma T0781 Trimethadione (N-demethylation) 1g 现货sigma A8676 Alprenolol (Ar hydrox) 5g 现货sigma A8404 Amitryptyline 10 g 现货sigma C1290 Chlorpropamide 25 g 现货sigma C5270 Cinnarizine (Ar hydrox) 10g 现货sigma C7291 Clomipramine 5 g 现货sigma C6305 Clozapine 100 mg 现货sigma C5901 Codeine 1g 现货sigma D1306 Debrisoquine (4) 100 mg 现货sigma F6777 Flecainide 25 mg 现货sigma F8257 Flunarizine (Ar hydrox) 1 g 现货sigma i2909 Indoramin 10 mg 现货sigma M9651 Maprotiline 1g 现货sigma M1641 Methoxyphenamine 5g 现货sigma M2727 Mexiletine 25 g 现货sigma M3157 Minaprine 1g 现货sigma N7261 Nortriptyline 10g 现货sigma p3028 Perhexiline 5g 现货sigma p6402 Perphenazine 5g 现货sigma p7045 Phenformin 10g 现货sigma p4670 Propafenone 5g 现货sigma T9025 Thioridazine 5g 现货sigma A8423 Amiodarone (N-deethylation) 1 g 现货sigma B7777 Budesonide (6?) 250mg 现货sigma 46158 Dapsone (N) 250mg 现货sigma D5878 Digitoxin (oxidation) 1 g 现货sigma L8533 Lansoprazole (sulfoxyde-oxidation) 250 mg 现货sigma L7757 Lidocaine (N-deethylation) 25 g 现货sigma M2147 Lovastatin 25 mg 7 现货sigma N7634 Nifedipine (dihydropyridine) 5g 现货sigma S7507 Sulfamethoxazole (N) 10g 现货sigma T9772 Triazolam 10 mg 现货sigma N6505 Nicotinamide adenine dinucleotide phosphate 100 mg 现货sigma F6889 Famotidine 现货sigma C0378 Chloramphenicol 现货sigma T1633 Theophylline 现货sigma T1500 testosterone 现货sigma B9300 benzoicacid 现货sigma L1011 Labetalol hydrochloride 现货sigma S7507 Sulfamethoxazole 现货sigma B4144 Bromazepam 现货sigma D0899 Diazepam 现货sigma T7883 Trimethoprim 现货sigma Q1125 Quinine HCl 现货sigma D6899 Diclofenac sodium salt 现货sigma S0883 Sulfasalazine 现货sigma N144 Nitrendipine 现货sigma T9652 Terfenadine 现货sigma F9677 Felodipine 现货sigma N3889 Nitrazepam 现货sigma C4024 Carbamazepine 现货sigma C0750 Caffeine 现货sigma F4381 Furosemide 现货sigma K1751 Ketoprofen 现货sigma N9890 Norfloxacin 现货sigma C3045 Cholesterol 现货sigma G2878 Glycocholic acid hydrate 现货sigma P3556 L-α-Phosphatidylcholine 现货sigma D221104 Dodecane 现货sigma M8389 MOPSO 现货sigma FOR P450 inhibition 现货sigma N0505 NADP+ 现货sigma G7250 Glucose-6-phosphate 现货sigma G6378 G6PDH 现货sigma F-124 furafylline 现货sigma p8511 tranylcypromine 现货sigma UC455 CEC (3-cyano-7-ethoxycoumarin) 现货sigma F6377 Fluorescein 现货sigma 28605 CHC (3-cyano-7-hydroxycoumarin) 现货sigma L8533 Lansoprazole 现货sigma C4740 Cisapride 现货sigma N5757 alpha-naphthoflavone 现货sigma S6319 sertraline hydrochloride 现货sigma T6654 Ticlopidine hydrochloride 现货sigma 74437 Nootkatone 现货sigma 30024 Cyclosporin A 现货sigma 22530 Quinacrine 现货sigma B5016 Bepridil 现货sigma N149 Nimodipine 现货sigma F132 Fluoxetine 现货sigma M8046 Mifepristone 现货sigma 10798 Apigenin 现货sigma 0 2644 7-ethoxycoumarin 现货sigma M3512 Miconazole 现货sigma I4883 Ibuprofen 现货sigma F8929 Fluconazole 现货sigma 62630 Lobeline 现货sigma H1512 Haloperidol 现货sigma M2727 Mexiletine 现货sigma C6628 chloroquine 现货sigma D1306 Debrisoquine sulfate 现货sigma Q0125 Quercetin 现货sigma T0891 Tolbutamide 现货sigma 67580 4-Methylimidazole 现货sigma 4-methylpyrazole 现货sigma C6019 Clotrimazole 现货sigma A6424 Astemizole 现货sigma N7510 Nicardipine hydrochloride 现货sigma M5441 Mibefradil dihydrochloride hydrate 现货sigma I6657 Itraconazole 现货sigma B5774 Benzbromarone 现货sigma Fluvoxamine 现货sigma E4876 17α-Ethynylestradiol 现货sigma 01338 Bergamottin 现货sigma UC431 4-OH-midazolam 现货sigma n4505 500mg 现货sigma n1511 1g 现货sigma c5275-5mg concanavalin a form canavalia ensiformis 5mg 现货sigma a0937-1g norepinephrine bitartrate salt 1g 现货sigma c7527-100g Choline chloride cell culture tested 100g 现货sigma I6504-500mg Isoproterenol hydrochloride 500mg 现货sigma M5379-250mg L Methionine sulfoximine 250mg 现货sigma L9634-1g Laminarin from Laminaria digitata 1g 现货sigma F7131-100mg N 3 2 Furyl acryloyl]-Phe-Gly-Gly 100mg 现货sigma L8754-5mg Lectin from Phaseolus vulgaris (red kidney bean) Phytohemaggluti 5mg 现货sigma T5910-5g 2,3,5-Triiodobenzoic acid 5g 现货sigma E1253-100mg E1253 Estriol 100mg 现货sigma D9891-1G Doxycycline hyclate 1g 现货sigma F2878-100g Ficoll PM70 100g 现货sigma D5879-100ml D5879 DMSO 100ml 现货sigma I5879-100mg Isobutyl 1 methylxanthine 100mg 现货sigma D1756-25mg Dexamethasone 25mg 现货sigma I5500-50mg Insulin from bovine pancreas 50mg 现货sigma N5764-5g Nisin from Lactococcus lactis 2.5% 5g 现货sigma H1384-1g Hypotaurine 1g 现货sigma C7352-25g L-Cysteine 25g 现货sigma H3506-1g Hyaluronidase from bovine testes Type I-S, lyophilized 1g 现货sigma L4263-100ml Sodium DL lactate solution syrup 100ml 现货sigma B2261-25mg bisBenzimide H 33342 trihydrochloride 25mg 现货sigma D4263-5VL Deoxyribonuclease I from bovine pancreas Standardized vial 5VL 现货sigma a3307-5mg Sialyllactose sodium salt 5mg 现货sigma C9210-5g Cyanogen bromide activated Agarose lyophilized powder 5g 现货sigma S1782-0.2mg 3 Sialyl Lewis X tetrasaccharide 0.2mg 现货sigma c4805-5g b Cyclodextrin powder 5g 现货sigma D0627-25mg Dibutyryl cAMP 25mg 现货sigma S5265-25KU streptolysin 25KU 现货sigma R7256-100ml R7256 RPMI1640 100ml 现货sigma c8518-10g Cesium hydroxide hydrate 10g 现货sigma d95204-100g 100g 现货sigma c9253 Cholesteryl oleate ≥98%1g 现货sigma e6005-5g 现货sigma 15139 Bisphenol F bis(3-chloro-2-hydroxypropyl) ether 250mg 现货sigma 299537 Trifluoroacetic acid 100g 现货sigma 545201 Cucurbit[7]uril 100mg 现货sigma 545228 Cucurbit[8]uril 100mg 现货sigma T8949 Telmisartan 10mg 现货sigma D141 DigitoninSigma BSA 牛血清白蛋白A3912-10gSigma Cholesterol 胆固醇C8667-5g Sigma Indomethacin 吲哚美辛I7378-5gSigma Dexamethasone 地塞米松D1756-100mgSigma L-Ascorbic acid维生素C A4544-25GSigma insulin 牛胰岛素I5500-100mg Sigma Oil Red O 油红O O0625-25g Sigma LPS 脂多糖L2880-25mgSigma MTT 噻唑兰M2128-100mgSigma BrDu 溴脱氧尿嘧啶核苷B5002-500mg Sigma Proteinase K蛋白酶K P6556-25mg/100mgSigma Trypan Blue台盼蓝T6146-5gSigma Uracil 尿嘧啶U0750-5gSigma Thymidine 胸苷T9250-1gSigma L-Cysteine hydrochloride 半胱氨酸盐酸盐C1276-10G Sigma Ethambutol dihydrochloride E4630-25GSigma Phenol Red 酚红P3532-5GSigma Ethambutol dihydrochloride 盐酸乙胺丁醇E4630-25G Sigma Sodium tripolyphosphate 三聚磷酸钠238503-25G sigma Palmitic acid棕榈酸P5585-10Gsigma Levofloxacin左氧氟沙星28266-10G-Fsigma L-Tryptophan L-色氨酸T0254-1G。
安捷伦产品目录
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Real-Time PCR
16
Mx3000P QPCR System
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Brilliant III Ultra-Fast SYBR Green QPCR and QRT-PCR Reagents
18
Brilliant III Ultra-Fast QPCR and QRT-PCR Reagents
Agilent / STRATAGENE
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適用於 UNG 去汙染或 bisulphite
sequencing
適用於 TA Cloning
最高敏感性
取代傳統 Taq 的好選擇
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威健股份有限公司 | Stratagene 總代理
PCR Enzyme & Instrument
Agilent SureCycler 8800
市場上領先的 cycling 速度和 sample 體積 10 ～ 100 μL 簡易快速可以選擇 96 well 和 384 well 操作盤 優秀的溫控設備讓各個 well 都能保持溫度的穩定 七吋的高解析度觸控螢幕讓操作上更為簡便 可以透過網路遠端操控儀器及監控儀器 Agilent 專業的技術支援可以幫助您應對各種 PCR 的問題
北京春达科技有限公司专营进口体外诊断试剂工业原料，透析产品，纯化填料，标准品
北京春达科技有限公司专营进⼝体外诊断试剂⼯业原料，透析产品，纯化填料，标准品SCLPP209碱性磷酸酶3.1.3.1Alkaline phosphatase from Calf intestine-Activity: >30000 U/mlGlycerol solution-Mw: 100,000-Store at -20 °CSCMAD211苹果酸脱氢酶1.1.1.37Malate dehydrogenase from Microorganism-Activity: >40 U/mgYellowish amorphous powder-Mw: 140,000-Store at -20 °CSCMDH18C苹果酸脱氢酶1.1.1.37Malate dehydrogenase from Pig heart-Activity: >1250 U/mgprot.White amorphous powder-Mw:140,000-Store at -20 °CSCMDL100苹果酸脱氢酶1.1.1.37Malate dehydrogenase from Microorganism-Activity: >60 U/mgWhite amorphous powder-Mw: 80,000-Store at -20 °CSCMUT11C变旋酶5.1.3.3Mutarotase from Porcine kidney-Activity: >1500 U/mgWhite amorphous powder-Mw: 40,000-Store at -20 °CSCMUT12C变旋酶5.1.3.3Mutarotase from Porcine kidney-Activity: >1000 U/mlAmmonium sulfate suspension-Mw: 40,000-Store at 2-8 °CSCNAL301唾液酸醛缩酶4.1.3.3N-Acetylneuraminic acid aldolase from MicroorganismActivity: >15 U/mg-Yellowish amorphous powderMw: 98,000-Store at -20 °CSCPCO301原⼉茶酸3,4双加氧酶1.13.11.3Protocatechuate 3,4-dioxygenase from Pseudomonas sp.Activity: >3 U/mg-Light brown amorphous powderMw: 700,000-Store at -20 °CSCPEO131过氧化物酶1.11.1.7Peroxidase from Horseradish, Grade IActivity: >250 U/mg-Reddish-brown amorphous powderMw: 40,000-Store at -20 °CSCPEO301过氧化物酶1.11.1.7Peroxidase from Horseradish, Grade I-Activity: >250 U/mgReddish-brown amorphous powder-Mw: 40,000-Store at -20°CSCPEO302过氧化物酶1.11.1.7Peroxidase from Horseradish, Grade III-Activity: >110 U/mgReddish-brown amorphous powder-Mw: 40,000-Store at -20°CSCPHO12C磷脂酶D Phospholipase D from Streptomyces chromofuscus3.1.4.4Activity: >40 U/mg-Brown amorphous powderMw: 57,000-Store at -20 °CSCPNP301嘌呤核苷磷酸化酶2.4.2.1Purine-nucleoside phosphorylase from MicroorganismActivity: >15 U/mg-White amorphous powderMw: 120,000-Store at -20 °CSCPPC301磷酸烯醇式丙酮酸羧化酶4.1.1.31Phosphoenolpyruvate carboxylase from Corn leavesActivity: >5 U/mg-White amorphous powderMw: 390,000-Store at -20 °CSCPSP101脯氨酸特定的肽链内切酶3.4.21.26Proline specific endopeptidase from Flavobacterium sp.Activity: >5 U/mg-White amorphous powder-Mw: 78,000-Store at -20 °CSCPYK302L丙酮酸激酶2.7.1.40Pyruvate kinase from Rabbit muscle-Activity:＞2000 U/mlwhite ammonium sulphate suspension-Mw:237000-Store at 2-8℃SCPYO311丙酮酸氧化酶1.2.3.3Pyruvate oxidase from Microorganism-Activity: >1.5 U/mgYellowish amorphous powder-Mw: 260,000-Store at -20 °CSCSAO341肌氨酸氧化酶1.5.3.1Sarcosine oxidase from Microorganism-Activity: >8 U/mgYellowish amorphous powder-Mw: 65,000-Store at -20 °CSCSAO351肌氨酸氧化酶1.5.3.1Sarcosine oxidase from Microorganism-Activity: >8 U/mgYellowish amorphous powder-Mw: 43,000-Store at -20 °CSCSOD302超氧化物歧化酶1.15.1.1Superoxide dismutase from Bovine erythrocyte-Activity: >3000U/mgBluish-green amorphous powder-Mw: 32,000-Store at -20 °CSCUAO201尿酸酶1.7.3.3Uricase from Candida sp.-Activity: >4 U/mg-White amorphous powder-Mw: 120,000-Store at -20 °CSCUAO211尿酸酶1.7.3.3Uricase from Bacillus sp.-Activity:>1.5 U/mg-White amorphous powder-Mw: 150,000-Store at -20 °CSCURH10S脲酶3.5.1.5Urease from Jack bean-Activity: >220 U/mg-White amorphous powder-Mw: 480,000-Store at -20 °CSCURH16C脲素酶GUrease G from Jack bean-Activity: >150 U/mgWhite amorphous powder-Mw: 480,000-Store at -20 °C3.5.1.5SCURH201脲素酶Urease from Jack bean-Activity: >100 U/mgWhite amorphous powder-Mw: 480,000-Store at -20 °C3.5.1.5SCXTO212黄嘌呤氧化酶Xanthine oxidase from Microorganism-Activity: >10 U/mgReddish-brown amorphous powder-Mw: 160,000-Store at -20°C1.1.3.222.诊断与研究⽤的辅酶CODES PRODUCTS CAS #SCADP01C 腺苷5'-⼆磷酸单钾盐⼆⽔合物ADP-K.2H2O-Adenosine 5’-diphosphate monopotasium saltdihydrate-C10H14N5O10P2K.2H2O-Mw:501.30-Colorless crystals-Purity:>95 %72696-48-1SCADP22C 腺苷5’-⼆磷酸⼆钠盐ADP-Na2-Adenosine 5’-diphosphate disodium salt-C10H13N5O10P2Na2-Mw:471.20-White powder-Purity:>98 %16178-48-6SCAMP02C 腺苷-5’-磷酸AMP-Adenosine 5’-monophosphoric acid-C10H14N5O7P.H2O-Mw:365.20-White powder-Purity:>98 %18422-05-4SCAMP05C 腺苷5’-磷酸AMP-Na2-Adenosine 5’-monophosphate disodium salt -C10H12N5O7PNa2-Mw:391.18-White powder-Purity:>95%18422-05-4SCATP03C 腺苷5’-三磷酸⼆钠盐3⽔合物ATP-Na2.3H2O-Adenosine 5’-triphosphate disodium salttrihydrate -C10H14N5Na2O13P3.3H2O -Mw:605.19-White powder-Purity:>96 %987-65-5SCBNA207C β-烟酰胺-腺嘌呤⼆核苷酸NAD-β-Nicotinamide-adenine dinucleotide-C21H27N7O14P2-Mw:663.4-White powder-Purity:>98 %53-84-9SCBND210C β-烟酰胺腺嘌呤⼆核苷磷酸，还原型四钠盐NADPH-Na4-β-Nicotinamide-adenine dinucleotide phosphate, reducedtetrasodium salt-C21H26N7O17P3.Na4-Mw:833.40-White powder-Purity:>93 %2646-71-1SCBNH208C β-烟酰胺腺嘌呤⼆核苷酸，还原⼆钠盐NADH-Na2-β-Nicotinamide-adenine dinucleotide, reduceddisodium salt -C21H27N7P2O14Na2-Mw:709.40-White to yellowish powder-Purity:>93 %606-68-8β-烟酰胺腺嘌呤⼆核苷酸磷酸⼆钠盐24292-60-2SCBNP209C β-烟酰胺腺嘌呤⼆核苷酸磷酸⼆钠盐NADP-Na2-β-Nicotinamide-adenine dinucleotide phosphatedisodium salt-C21H26N7O17P3Na2-Mw:787.40-Yellowishpowder-Purity:>97 %24292-60-2SCCOA11C 辅酶A三锂盐Coenzyme A trilithium salt-C21H33Li3N16O7P3S-Mw:785.40-White powder-Purity:>85 %18439-24-2SCDAD631C ⼆(腺苷-5’-)五磷酸三锂盐Ap5A-Li3-P1,P5 –Di(adenosine -5’-)pentaphosphate trilithiumsalt-C20H26N10O22P5Li3-Mw:934.20-Yellowish powder-Purity:>95 %75522-97-3SCFAD11C 黄素腺嘌呤⼆核苷酸⼆钠盐FAD- Na2-Flavine-adenine dinucleotide disodium salt-C27H31N9O15P2Na2-Mw:829.60-Orange powder-Purity:>93 %146-14-5SCNAL24C N-⼄酰-L-半胱氨酸N-Acetyl-L-cysteine-C5H9NO3S-Mw:163.20-White powder-Purity:>98 %616-91-1SASNAD 硫代辅酶IThio-NAD-C21H27N7O13SP2-Purity:≥ 90%4090-29-3SASNADP 硫代辅酶IIThio-NADP-C21H27N7O16P3S•Na- Purity:≥ 90%19254-05-8SAAldNAD 3-吡啶⼄醛腺嘌呤⼆核苷酸3-Pyridinealdehyde adenine dinucleotide C21H27N6O14P21986-7-7SAAC1023-⼄酰基吡啶腺嘌呤⼆核苷酸磷酸钠(Ac-NADP) APADP-C22H28N6O17P3•Na -Purity:≥ 80%102029-67-4SANAAD 烟酸腺嘌呤⼆核苷酸Nicotinic Acid Adenine Dinucleotide- C21H26N6O15P2104809-30-5SADeNAD 脱氨基NADDeamino Nicotinamide Adenine Dinucleotide-C21H26N6O15P2104809-38-3SAGGNAFB γ-L-⾕氨酰基-4-硝基苯胺Gamma-L-glutamyl-4-nitroanilide,-C11H13N3O5-Purity:≥ 96%7300-59-6SACGGN L-γ-⾕氨酸-(3-甲酸-4硝基苯胺)铵盐L-Glutamic Acid Gamma- (3-Carboxy-4-Nitroanilide),Ammonium Salt-C12H12N3O7P•NH4-Purity:≥ 96%63699-78-5SAPEPCHA 磷酸烯醇丙酮酸单环⼰胺盐PEP-C3H4O6P•C6H13N-Purity :＞95%10526-80-4SAPEPK 磷酸烯醇式丙酮酸单钾盐PEP-C3H4O6P•K-Purity :＞95%4265-07-03.诊断与研究⽤的底物CODES PRODUCTS CAS #SCAKE05C α–酮戊⼆酸⼆钠盐⼆⽔合物α–Ketoglutaric acid, disodium salt dihydrate-C5H4O5Na2.2H2O-Mw:226.10 -White powder-Purity:>98%305-72-6α–酮戊⼆游离酸328-50-7SCAKE115C α–酮戊⼆游离酸α–Ketoglutaric free acid-C5H4O5-Mw:146.10 -White powder-Purity:>99%328-50-7SCBTC06S-丁酰硫胆碱碘S-Butyrylthiocholine Iodide-C9H20NOSI-Mw:317.23 -White powder-Purity:>97%1866-16-6SCCNP005Gal-G2-α-CNP-C28H51O18Cl-Mw:659.98 -White powder-Purity:>90 %157381-11-8SCCRP59C 磷酸肌酸⼆钠盐四⽔合物Phosphocreatine disodium salt tetrahydrate-C4H8N3O5PNa2.4H2O-Mw:327.15 -White powder-Purity:>97 %19333-65-4SCGGC106C ⽢氨酰⽢氨酸Glycylglycine-C4H8N2O3-Mw:132.12-White powder-Purity:>98 %556-50-3SCGLT100L-⾕氨酸L-Glutamic acid-C5H9N2O4- Mw:147.13-White powder-purity:＞99%617-65-2SCGPS15C 葡萄糖-6-磷酸⼆钠盐Glucose-6-phosphate disodium salt-C6H11O9PNa2-Mw:304.20-White powder-Purity:>95 %3671-99-6SCLAC171C DL-乳酸锂盐DL-Lactic acid Lithium salt-C3H5O3Li-Mw:96.01-White powder-Purity:>95%16891-53-5SCLAL29C L-丙氨酸游离酸L-Alanine free acid-C3H7NO2-Mw:89.09-White powder-Purity:>99%56-41-7SCLAP41C L-天门冬氨酸L-Aspartic acid-C4H7NO4-Mw:133.10-White powder-Purity:>99 %56-84-8SCLAP42C L-天门冬氨酸,钠盐⼀⽔合物L-Aspartic acid, sodium salt monohydrate-C4H6NO4Na.H2O-Mw:173.10-White powder-Purity:>98 %323194-76-9SCLAP43C L-天门冬氨酸,镁⼆⽔合物L-Aspartic acid, magnesium salt dihydrate-C8H12N2O8Mg.2H2O-MW:324.50-White powder-Purity:>98 %2068-80-6SCLGC244C L-γ-⾕氨酰-3-羧基-4-硝基苯胺Glupa C-L-γ-Glutamyl-3-carboxy-4-nitranilide-C12H12N3O7NH4-Mw:328.30-Yellow powder-Purity:>99 %63699-78-5SCNAY138C 萘磷酸单钠盐Naphtyl phosphate, monosodium salt-C10H8NaO4P.H2O-Mw:264.15-White powder-Purity:>98%81012-89-7SCPG701C 亚⼄基降-4-硝基苯基-β-D-麦芽庚糖苷pNP-G7-Ethylidene-4-nitrophenyl-D-maltoheptaoside-C50H77NO38-Mw:1300.10-Yellowish powder-Purity:>90%96597-16-9对硝基苯基磷酸酯，⼆钠盐六⽔合物4264-83-9SCPNP264C 对硝基苯基磷酸酯，⼆钠盐六⽔合物PNPP-p-Nitrophenylphosphate, disodium salt hexahydrate-C6H4NO6PNa2.6H2O-Mw :371.10-White to yellow powder-Purity:>98%4264-83-9SCPNS265C p-硝基苯基磷酸酯，⼆tris盐PNPP diTris-p-Nitrophenylphosphate, ditris salt-C14H28N3O12P-Mw:461.40-White powder68189-42-4SCPYN100丙酮酸钠Sodium pyruvate-C3H3NaO3-Mw:110-White powder-Purity:>99%113-24-64.缓冲液Buffers for diagnostic & researchPRODUCTS CAS # N-(2-⼄酰胺基)-2-氨基⼄磺酸ACES-N-(2-Acetamido)-2-aminoethanesulfonic acid7365-82-4N-(2-⼄酰胺基)亚氨基⼆⼄酸ADA-(N-(2-Acetamido)iminodiacetic acid)26239-55-4 2-氨基-2-甲基-1-丙醇AMT -2-amino-2-methyl-1-propanol124-68-5 N,N-双(2-羟⼄基)-2-氨基⼄磺酸BES-N,N-Bis-(2-Hydroxyethyl)-2-Aminoethanesulfonic acid10191-18-1 N,N-双-(2-羟基⼄基)⽢氨酸Bicine-N,N-Bis-(2-Hydroxyethyl)glycine150-25-4 N-环⼰基-3-氨基丙磺酸CAPS-N-Cyclohexyl-3-aminopropanesulfonicacid1135-40-6N-环⼰基-2-羟基-3-氨基丙磺酸CAPSO -N-Cyclohexyl-2-hydroxy-3-aminopropanesulfonic acid73463-39-5。
Bioanalytical Method ValidationGuidance for Indust
Guidance for Industry Bioanalytical Method ValidationU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Veterinary Medicine (CVM)May 2001BPGuidance for Industry Bioanalytical Method ValidationAdditional copies are available from:Drug Information Branch (HFD-210)Center for Drug Evaluation and Research (CDER)5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573Internet at /cder/guidance/index.htmorCommunications Staff (HFV-12)Center for Veterinary Medicine (CVM)7500 Standish Place, Rockville, MD 20855 (Tel) 301–594-1755Internet at /cvmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Veterinary Medicine (CVM)May 2001BPTable of ContentsI.INTRODUCTION (1)II.BACKGROUND (1)A.F ULL V ALIDATION (2)B.P ARTIAL V ALIDATION (2)C.C ROSS-V ALIDATION (3)III.REFERENCE STANDARD (4)IV.METHOD DEVELOPMENT: CHEMICAL ASSAY (4)A.S ELECTIVITY (4)B.A CCURACY, P RECISION, AND R ECOVERY (5)C.C ALIBRATION/S TANDARD C URVE (5)D.S TABILITY (6)E.P RINCIPLES OF B IOANALYTICAL M ETHOD V ALIDATION AND E STABLISHMENT (8)F.S PECIFIC R ECOMMENDATIONS FOR M ETHOD V ALIDATION (10)V.METHOD DEVELOPMENT: MICROBIOLOGICAL AND LIGAND-BINDING ASSAYS (11)A.S ELECTIVITY I SSUES (11)B.Q UANTIFICATION I SSUES (12)VI.APPLICATION OF VALIDATED METHOD TO ROUTINE DRUG ANALYSIS (13)A CCEPTANCE C RITERIA FOR THE R UN (15)VII.DOCUMENTATION (16)A.S UMMARY I NFORMATION (16)B.D OCUMENTATION FOR M ETHOD E STABLISHMENT (17)C.A PPLICATION TO R OUTINE D RUG A NALYSIS (17)D.O THER I NFORMATION (19)GLOSSARY (20)GUIDANCE FOR INDUSTRY1Bioanalytical Method ValidationI.INTRODUCTIONThis guidance provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies requiring pharmacokinetic (PK) evaluation. This guidance also applies to bioanalytical methods used for non-human pharmacology/toxicology studies and preclinical studies. For studies related to the veterinary drug approval process, this guidance applies only to blood and urine BA, BE, and PK studies.The information in this guidance generally applies to bioanalytical procedures such as gas chromatography (GC), high-pressure liquid chromatography (LC), combined GC and LC mass spectrometric (MS) procedures such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS performed for the quantitative determination of drugs and/or metabolites in biological matricessuch as blood, serum, plasma, or urine. This guidance also applies to other bioanalytical methods, such as immunological and microbiological procedures, and to other biological matrices, such as tissue and skin samples.This guidance provides general recommendations for bioanalytical method validation. The recommendations can be adjusted or modified depending on the specific type of analytical method used. II.BACKGROUND1 This guidance has been prepared by the Biopharmaceutics Coordinating Committee in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Veterinary Medicine (CVM) at the Food and Drug Administration.This guidance has been developed based on the deliberations of two workshops: (1) Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies (held on December 3B5, 19902 ) and (2) Bioanalytical Methods Validation C A Revisit With a Decade of Progress (held on January 12B14, 20003).Selective and sensitive analytical methods for the quantitative evaluation of drugs and their metabolites (analytes) are critical for the successful conduct of preclinical and/or biopharmaceutics and clinical pharmacology studies. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use. The fundamental parameters for this validation include (1) accuracy, (2) precision, (3) selectivity, (4) sensitivity, (5) reproducibility, and (6) stability. Validation involves documenting, through the use of specific laboratory investigations, that the performance characteristics of the method are suitable and reliable for the intended analytical applications. The acceptability of analytical data corresponds directly to the criteria used to validate the method.Published methods of analysis are often modified to suit the requirements of the laboratory performing the assay. These modifications should be validated to ensure suitable performance of the analytical method. When changes are made to a previously validated method, the analyst should exercise judgment as to how much additional validation is needed. During the course of a typical drug development program, a defined bioanalytical method undergoes many modifications. The evolutionary changes to support specific studies and different levels of validation demonstrate the validity of an assay’s performance. Different types and levels of validation are defined and characterized as follows:A.Full Validation•Full validation is important when developing and implementing a bioanalytical method for the first time.•Full validation is important for a new drug entity.• A full validation of the revised assay is important if metabolites are added to an existing assay for quantification.B.Partial ValidationPartial validations are modifications of already validated bioanalytical methods. Partial validation can range from as little as one intra-assay accuracy and precision determination to a nearly full2 Workshop Report: Shah, V.P. et al., Pharmaceutical Research: 1992; 9:588-592.3 Workshop Report: Shah, V.P. et al., Pharmaceutical Research: 2000; 17:in press.validation. Typical bioanalytical method changes that fall into this category include, but are not limited to:•Bioanalytical method transfers between laboratories or analysts•Change in analytical methodology (e.g., change in detection systems)•Change in anticoagulant in harvesting biological fluid•Change in matrix within species (e.g., human plasma to human urine)•Change in sample processing procedures•Change in species within matrix (e.g., rat plasma to mouse plasma)•Change in relevant concentration range•Changes in instruments and/or software platforms•Limited sample volume (e.g., pediatric study)•Rare matrices•Selectivity demonstration of an analyte in the presence of concomitant medications•Selectivity demonstration of an analyte in the presence of specific metabolitesC.Cross-ValidationCross-validation is a comparison of validation parameters when two or more bioanalytical methods are used to generate data within the same study or across different studies. An example of cross-validation would be a situation where an original validated bioanalytical method serves as thereference and the revised bioanalytical method is the comparator. The comparisons should be done both ways.When sample analyses within a single study are conducted at more than one site or more than one laboratory, cross-validation with spiked matrix standards and subject samples should be conducted at each site or laboratory to establish interlaboratory reliability. Cross-validation should also be considered when data generated using different analytical techniques (e.g., LC-MS-MS vs.ELISA4) in different studies are included in a regulatory submission.All modifications should be assessed to determine the recommended degree of validation. The analytical laboratory conducting pharmacology/toxicology and other preclinical studies for regulatory submissions should adhere to FDA=s Good Laboratory Practices (GLPs)5 (21 CFR part 58) and to sound principles of quality assurance throughout the testing process. The bioanalytical method for human BA, BE, PK, and drug interaction studies must meet the criteria in 21 CFR 320.29. The analytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. The SOPs also should include record keeping, security and chain of sample custody4 Enzyme linked immune sorbent assay5 For the Center for Veterinary Medicine, all bioequivalence studies are subject to Good Laboratory Practices.(accountability systems that ensure integrity of test articles), sample preparation, and analytical tools such as methods, reagents, equipment, instrumentation, and procedures for quality control and verification of results.The process by which a specific bioanalytical method is developed, validated, and used in routine sample analysis can be divided into (1) reference standard preparation, (2) bioanalytical method development and establishment of assay procedure, and (3) application of validated bioanalytical method to routine drug analysis and acceptance criteria for the analytical run and/or batch. These three processes are described in the following sections of this guidance.III.REFERENCE STANDARDAnalysis of drugs and their metabolites in a biological matrix is carried out using samples spiked with calibration (reference) standards and using quality control (QC) samples. The purity of the reference standard used to prepare spiked samples can affect study data. For this reason, an authenticated analytical reference standard of known identity and purity should be used to prepare solutions of known concentrations. If possible, the reference standard should be identical to the analyte. When this is not possible, an established chemical form (free base or acid, salt or ester) of known purity can be used. Three types of reference standards are usually used: (1) certified reference standards (e.g., USP compendial standards); (2) commercially supplied reference standards obtained from a reputable commercial source; and/or (3) other materials of documented purity custom-synthesized by an analytical laboratory or other noncommercial establishment. The source and lot number, expiration date, certificates of analyses when available, and/or internally or externally generated evidence of identity and purity should be furnished for each reference standard.IV.METHOD DEVELOPMENT: CHEMICAL ASSAYThe method development and establishment phase defines the chemical assay. The fundamental parameters for a bioanalytical method validation are accuracy, precision, selectivity, sensitivity, reproducibility, and stability. Measurements for each analyte in the biological matrix should be validated. In addition, the stability of the analyte in spiked samples should be determined. Typical method development and establishment for a bioanalytical method include determination of (1) selectivity, (2) accuracy, precision, recovery, (3) calibration curve, and (4) stability of analyte in spiked samples.A.SelectivitySelectivity is the ability of an analytical method to differentiate and quantify the analyte in thepresence of other components in the sample. For selectivity, analyses of blank samples of theappropriate biological matrix (plasma, urine, or other matrix) should be obtained from at leastsix sources. Each blank sample should be tested for interference, and selectivity should be ensured at the lower limit of quantification (LLOQ).Potential interfering substances in a biological matrix include endogenous matrix components, metabolites, decomposition products, and in the actual study, concomitant medication and other exogenous xenobiotics. If the method is intended to quantify more than one analyte, each analyte should be tested to ensure that there is no interference.B.Accuracy, Precision, and RecoveryThe accuracy of an analytical method describes the closeness of mean test results obtained by the method to the true value (concentration) of the analyte. Accuracy is determined by replicate analysis of samples containing known amounts of the analyte. Accuracy should be measured using a minimum of five determinations per concentration. A minimum of three concentrations in the range of expected concentrations is recommended. The mean value should be within 15% of the actual value except at LLOQ, where it should not deviate by more than 20%. The deviation of the mean from the true value serves as the measure of accuracy.The precision of an analytical method describes the closeness of individual measures of an analyte when the procedure is applied repeatedly to multiple aliquots of a single homogeneous volume of biological matrix. Precision should be measured using a minimum of five determinations per concentration. A minimum of three concentrations in the range of expected concentrations is recommended. The precision determined at each concentration level should not exceed 15% of the coefficient of variation (CV) except for the LLOQ, where it should not exceed 20% of the CV. Precision is further subdivided into within-run, intra-batch precision or repeatability, which assesses precision during a single analytical run, and between-run, inter-batch precision or repeatability, which measures precision with time, and may involve different analysts, equipment, reagents, and laboratories.The recovery of an analyte in an assay is the detector response obtained from an amount of the analyte added to and extracted from the biological matrix, compared to the detector response obtained for the true concentration of the pure authentic standard. Recovery pertains to the extraction efficiency of an analytical method within the limits of variability. Recovery of the analyte need not be 100%, but the extent of recovery of an analyte and of the internal standard should be consistent, precise, and reproducible. Recovery experiments should be performed by comparing the analytical results for extracted samples at three concentrations (low, medium, and high) with unextracted standards that represent 100% recovery.C.Calibration/Standard CurveA calibration (standard) curve is the relationship between instrument response and known concentrations of the analyte. A calibration curve should be generated for each analyte in thesample. A sufficient number of standards should be used to adequately define the relationship between concentration and response. A calibration curve should be prepared in the same biological matrix as the samples in the intended study by spiking the matrix with known concentrations of the analyte. The number of standards used in constructing a calibration curve will be a function of the anticipated range of analytical values and the nature of theanalyte/response relationship. Concentrations of standards should be chosen on the basis of the concentration range expected in a particular study. A calibration curve should consist of a blank sample (matrix sample processed without internal standard), a zero sample (matrix sample processed with internal standard), and six to eight non-zero samples covering the expected range, including LLOQ.1.Lower Limit of Quantification (LLOQ)The lowest standard on the calibration curve should be accepted as the limit ofquantification if the following conditions are met:C The analyte response at the LLOQ should be at least 5 times the responsecompared to blank response.C Analyte peak (response) should be identifiable, discrete, and reproducible witha precision of 20% and accuracy of 80-120%.2.Calibration Curve/Standard Curve/Concentration-ResponseThe simplest model that adequately describes the concentration-response relationshipshould be used. Selection of weighting and use of a complex regression equation should be justified. The following conditions should be met in developing a calibration curve:C#20% deviation of the LLOQ from nominal concentrationC#15% deviation of standards other than LLOQ from nominal concentrationAt least four out of six non-zero standards should meet the above criteria, including the LLOQ and the calibration standard at the highest concentration. Excluding thestandards should not change the model used.D.StabilityDrug stability in a biological fluid is a function of the storage conditions, the chemical properties of the drug, the matrix, and the container system. The stability of an analyte in a particular matrix and container system is relevant only to that matrix and container system and should not be extrapolated to other matrices and container systems. Stability procedures should evaluate the stability of the analytes during sample collection and handling, after long-term (frozen at theintended storage temperature) and short-term (bench top, room temperature) storage, and after going through freeze and thaw cycles and the analytical process. Conditions used in stability experiments should reflect situations likely to be encountered during actual sample handling and analysis. The procedure should also include an evaluation of analyte stability in stock solution.All stability determinations should use a set of samples prepared from a freshly made stock solution of the analyte in the appropriate analyte-free, interference-free biological matrix. Stock solutions of the analyte for stability evaluation should be prepared in an appropriate solvent at known concentrations.1.Freeze and Thaw StabilityAnalyte stability should be determined after three freeze and thaw cycles. At least three aliquots at each of the low and high concentrations should be stored at the intendedstorage temperature for 24 hours and thawed unassisted at room temperature. Whencompletely thawed, the samples should be refrozen for 12 to 24 hours under the sameconditions. The freeze–thaw cycle should be repeated two more times, then analyzedon the third cycle. If an analyte is unstable at the intended storage temperature, thestability sample should be frozen at -700C during the three freeze and thaw cycles.2.Short-Term Temperature StabilityThree aliquots of each of the low and high concentrations should be thawed at roomtemperature and kept at this temperature from 4 to 24 hours (based on the expectedduration that samples will be maintained at room temperature in the intended study) and analyzed.3.Long-Term StabilityThe storage time in a long-term stability evaluation should exceed the time between the date of first sample collection and the date of last sample analysis. Long-term stabilityshould be determined by storing at least three aliquots of each of the low and highconcentrations under the same conditions as the study samples. The volume of samples should be sufficient for analysis on three separate occasions. The concentrations of allthe stability samples should be compared to the mean of back-calculated values for the standards at the appropriate concentrations from the first day of long-term stabilitytesting.4.Stock Solution StabilityThe stability of stock solutions of drug and the internal standard should be evaluated at room temperature for at least 6 hours. If the stock solutions are refrigerated or frozenfor the relevant period, the stability should be documented. After completion of thedesired storage time, the stability should be tested by comparing the instrumentresponse with that of freshly prepared solutions.5.Post-Preparative StabilityThe stability of processed samples, including the resident time in the autosampler, should be determined. The stability of the drug and the internal standard should be assessedover the anticipated run time for the batch size in validation samples by determiningconcentrations on the basis of original calibration standards.Although the traditional approach of comparing analytical results for stored samples with those for freshly prepared samples has been referred to in this guidance, other statistical approaches based on confidence limits for evaluation of an analyte=s stability in abiological matrix can be used. SOPs should clearly describe the statistical method andrules used. Additional validation may include investigation of samples from dosedsubjects.E.Principles of Bioanalytical Method Validation and Establishment•The fundamental parameters to ensure the acceptability of the performance of a bioanalytical method validation are accuracy, precision, selectivity, sensitivity,reproducibility, and stability.• A specific, detailed description of the bioanalytical method should be written. This can be in the form of a protocol, study plan, report, and/or SOP.•Each step in the method should be investigated to determine the extent to which environmental, matrix, material, or procedural variables can affect the estimation of analyte in the matrix from the time of collection of the material up to and including the time ofanalysis.•It may be important to consider the variability of the matrix due to the physiological nature of the sample. In the case of LC-MS-MS-based procedures, appropriate steps should be taken to ensure the lack of matrix effects throughout the application of the method,especially if the nature of the matrix changes from the matrix used during method validation.• A bioanalytical method should be validated for the intended use or application. All experiments used to make claims or draw conclusions about the validity of the methodshould be presented in a report (method validation report).•Whenever possible, the same biological matrix as the matrix in the intended samples should be used for validation purposes. (For tissues of limited availability, such as bone marrow, physiologically appropriate proxy matrices can be substituted.)•The stability of the analyte (drug and/or metabolite) in the matrix during the collection process and the sample storage period should be assessed, preferably prior to sampleanalysis.•For compounds with potentially labile metabolites, the stability of analyte in matrix from dosed subjects (or species) should be confirmed.•The accuracy, precision, reproducibility, response function, and selectivity of the method for endogenous substances, metabolites, and known degradation products should beestablished for the biological matrix. For selectivity, there should be evidence that thesubstance being quantified is the intended analyte.•The concentration range over which the analyte will be determined should be defined in the bioanalytical method, based on evaluation of actual standard samples over the range,including their statistical variation. This defines the standard curve.• A sufficient number of standards should be used to adequately define the relationship between concentration and response. The relationship between response and concentration should be demonstrated to be continuous and reproducible. The number of standards used should be a function of the dynamic range and nature of the concentration-responserelationship. In many cases, six to eight concentrations (excluding blank values) can define the standard curve. More standard concentrations may be recommended for nonlinear than for linear relationships.•The ability to dilute samples originally above the upper limit of the standard curve should be demonstrated by accuracy and precision parameters in the validation.•In consideration of high throughput analyses, including but not limited to multiplexing, multicolumn, and parallel systems, sufficient QC samples should be used to ensure control of the assay. The number of QC samples to ensure proper control of the assay should be determined based on the run size. The placement of QC samples should be judiciously considered in the run.•For a bioanalytical method to be considered valid, specific acceptance criteria should be set in advance and achieved for accuracy and precision for the validation of QC samples over the range of the standards.F.Specific Recommendations for Method Validation•The matrix-based standard curve should consist of a minimum of six standard points, excluding blanks, using single or replicate samples. The standard curve should cover the entire range of expected concentrations.•Standard curve fitting is determined by applying the simplest model that adequately describes the concentration-response relationship using appropriate weighting and statistical tests for goodness of fit.•LLOQ is the lowest concentration of the standard curve that can be measured with acceptable accuracy and precision. The LLOQ should be established using at least five samples independent of standards and determining the coefficient of variation and/orappropriate confidence interval. The LLOQ should serve as the lowest concentration on the standard curve and should not be confused with the limit of detection and/or the low QC sample. The highest standard will define the upper limit of quantification (ULOQ) of an analytical method.•For validation of the bioanalytical method, accuracy and precision should be determined using a minimum of five determinations per concentration level (excluding blank samples).The mean value should be within ±15% of the theoretical value, except at LLOQ, where it should not deviate by more than ±20%. The precision around the mean value should not exceed 15% of the CV, except for LLOQ, where it should not exceed 20% of the CV.Other methods of assessing accuracy and precision that meet these limits may be equally acceptable.•The accuracy and precision with which known concentrations of analyte in biological matrix can be determined should be demonstrated. This can be accomplished by analysis ofreplicate sets of analyte samples of known concentrations C QC samples C from anequivalent biological matrix. At a minimum, three concentrations representing the entire range of the standard curve should be studied: one within 3x the lower limit of quantification (LLOQ) (low QC sample), one near the center (middle QC), and one near the upperboundary of the standard curve (high QC).•Reported method validation data and the determination of accuracy and precision should include all outliers; however, calculations of accuracy and precision excluding values that are statistically determined as outliers can also be reported.•The stability of the analyte in biological matrix at intended storage temperatures should be established. The influence of freeze-thaw cycles (a minimum of three cycles at twoconcentrations in triplicate) should be studied.•The stability of the analyte in matrix at ambient temperature should be evaluated over a time period equal to the typical sample preparation, sample handling, and analytical run times.•Reinjection reproducibility should be evaluated to determine if an analytical run could be reanalyzed in the case of instrument failure.•The specificity of the assay methodology should be established using a minimum of six independent sources of the same matrix. For hyphenated mass spectrometry-basedmethods, however, testing six independent matrices for interference may not be important.In the case of LC-MS and LC-MS-MS-based procedures, matrix effects should beinvestigated to ensure that precision, selectivity, and sensitivity will not be compromised.Method selectivity should be evaluated during method development and throughout methodvalidation and can continue throughout application of the method to actual study samples.•Acceptance/rejection criteria for spiked, matrix-based calibration standards and validation QC samples should be based on the nominal (theoretical) concentration of analytes.Specific criteria can be set up in advance and achieved for accuracy and precision over therange of the standards, if so desired.V.METHOD DEVELOPMENT: MICROBIOLOGICAL AND LIGAND-BINDING ASSAYSMany of the bioanalytical validation parameters and principles discussed above are also applicable to microbiological and ligand-binding assays. However, these assays possess some unique characteristics that should be considered during method validation.A.Selectivity IssuesAs with chromatographic methods, microbiological and ligand-binding assays should be shown to be selective for the analyte. The following recommendations for dealing with two selectivity issues should be considered:1.Interference From Substances Physiochemically Similar to the Analyte•Cross-reactivity of metabolites, concomitant medications, or endogenouscompounds should be evaluated individually and in combination with the analyteof interest.•When possible, the immunoassay should be compared with a validated reference method (such as LC-MS) using incurred samples and predetermined criteria foragreement of accuracy of immunoassay and reference method.。
新冠防治急需医学装备目录(第四批
江阴滨江医疗设备有限公司
安徽华丰节能环保科技有限公司/中国
23
过氧化氢低温等离子
恩科思奈（苏州）环境科技有限公司 深圳市仁能达科技有限公司
上海力申科学仪器有限公司/中国
深圳市仁能达科技有限公司
以色列tuttnauer
瑞典洁定Getinge
24 压力蒸汽高压灭菌器 广州市铭鎏医疗器械有限公司/ 以色列tuttnauer
江阴滨江医疗设备有限公司
重庆优玛环试医疗设备有限公司
青岛永合创信电子科技有限公司/中国
深圳市美雅洁技术股份有限公司/中国
碧迪医疗器械（上海）有限公司，美国
广州市丰华生物工程有限公司/中国 广州市丰华生物工程有限公司/中国 广州市丰华生物工程有限公司/中国 广州市丰华生物工程有限公司/中国 广州市丰华生物工程有限公司/中国 广州市丰华生物工程有限公司/中国 广州市丰华生物工程有限公司/中国 广州市丰华生物工程有限公司/中国
600系列
DT-480/380/280
CompoMatG5全自动血液成分分离机
CX-2000、CX-2100
是否 外企
是 是
是 是 外企
是 是
第 2 页，共 16 页
No.
设备品目名称
参考生产厂/国别
17
血细胞分析仪 长春市博特生物科技有限公司
广州埃克森生物科技有限公司
江苏美诚生物科技有限公司
QIAGEN/德国
是否进入 是否 遴选目录 外企
是
是 是 是 是
长沙迪普美医疗科技有限公司/中国
DPfusionVP1、DPfusionVP3、DPfusionVP5
7
输液泵
佛山市艾米康医疗科技有限公司 史密斯医疗上海国际贸易有限公司/美国
15523666_迷迭香酸对哮喘小鼠氧化性肺损伤的保护作用
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【实验】转基因植物产品检测实验室一览
【关键字】实验转基因植物产品检测实验室一览其他设备：细胞融合仪、核酸提取仪、紫外分光光度计、核酸蛋白检测仪磁力搅拌机杂交仪、-30℃低温冰箱、超低温冰箱、漩涡混合器、超声波细胞粉碎仪、自动恒温酶标。
7 操作步骤7.1 抽样参照 NY/T672 转基因植物及其产品检测通用要求和NY/T673 转基因植物及其产品检测抽样。
7.2 制样参照 NY/T672 转基因植物及其产品检测通用要求和NY/T673 转基因植物及其产品检测抽样（按照GB 5491中四分法制备样品进行送检）。
7.3 DNA模板的制备a称取200-400 mg试样，在液氮中磨碎，装入已经用液氮预冷的1.5 ml离心管中。
b加入1ml预冷至4 ℃的抽提液，剧烈摇动混匀后，在冰上静置5分钟，用13 000 r/min离心机，4 ℃离心15 min，弃去上清液。
c加入600 μl 预热到65 ℃的抽提裂解液，用玻棒搅拌上下颠倒充分混匀，在65 ℃的水浴锅中裂解40 min。
d用13 000 r/min离心机室温离心10 min，将上清液转至另一离心管中，加入5 μl RNase A （10 mg/ml），37 ℃水浴30 min。
e分别用等体积苯酚：氯仿：异戊醇（25：24：1）和氯仿：异戊醇（24：1）各抽提一次。
f用13 000 r/min离心机室温离心10 min，将上清转至另一离心管中。
加入2/3体积异丙醇，1/10 体积3M乙酸钠（pH 5.6），-20 ℃放置2-3 h，充分沉淀DNA。
g13 000 r/min，4 ℃离心15 min，用70%乙醇洗沉淀一次，倒出乙醇，晾干DNA。
加入50 μl TE（pH8.0）溶解DNA。
h把DNA溶液浓度用重蒸馏水调制为100ng/μl，储存于-20 ℃备用。
注意：I 1 g试样（如棉花种子）提取的DNA量应不小于200 μg。
II DNA的OD260/OD280的比值应在1.8左右，且OD260的值应在曲线的最高峰。